Clinical TrialsNCT03964402
Sample Size for Multivariate Time-to-event Data
An observational study of Clinical Trials, run by Institut Bergonié at 1 site in France.
Trial summary
Most of randomized clinical trials (RCT) using time-to-event criteria as the primary endpoint are designed, powered and analyzed based on an hypothetical hazard ratio (HR) corresponding to the targeted effect size between experimental and control arms. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Clinical Trials
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any comparative clinical trial for which modern statistical methods are required to estimate sample size, in particular, it can be clinical trials : * with heterogeneous populations, * with recurrent event data, * involving a biomarker-Strategy Designs With Multiple Treatments.
Any comparative clinical trial for which modern statistical methods are required to estimate sample size
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sample Size Determination in Heterogeneous Populations for Multivariate Time-to-event Data
Most of randomized clinical trials (RCT) using time-to-event criteria as the primary endpoint are designed, powered and analyzed based on an hypothetical hazard ratio (HR) corresponding to the targeted effect size between experimental and control arms. Usually, one assumes that populations are homogeneous within each treatment arm, that is, within each arm, (i) the baseline risk is identical for all patients, and (ii) the treatment effect is identical for all patients. This assumption however may not hold in all circumstances. This project aims at providing a statistical method for the estimation of sample size in RCT, in the presence of heterogenous populations, such as assuming populations with distinct underlying baseline risks or assuming different treatment effects.
- Conditions
- Clinical Trials
- Keywords
- sample size, survival, randomized clinical trials, statistical test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Clinical trial | Corresponds to a comparative clinical trial for which our new statistical methods will be applied to estimate sample size |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
time from randomization to death
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Clinical TrialsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carine Bellera, PhD, Principal investigator, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964402
- Sponsor's protocol ID
- IB2018-SAMPLE-SIZE-SURVIVAL
- Status last verified
- Sep 2025
- First submitted
- 23 May 2019
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dinart D, Bellera C, Rondeau V. Sample size estimation for cancer randomized trials in the presence of heterogeneous populations. Biometrics. 2022 Dec;78(4):1662-1673. doi: 10.1111/biom.13527. Epub 2021 Sep 3.
PubMed 34242412Dinart D, Bellera C, Rondeau V. Sample size estimation for recurrent event data using multifrailty and multilevel survival models. J Biopharm Stat. 2025 Mar;35(2):241-256. doi: 10.1080/10543406.2024.2310306. Epub 2024 Feb 9.
PubMed 38334044Dinart D, Rondeau V, Bellera C. Sample Size Estimation Using a Partially Clustered Frailty Model for Biomarker-Strategy Designs With Multiple Treatments. Pharm Stat. 2024 Nov-Dec;23(6):1084-1094. doi: 10.1002/pst.2407. Epub 2024 Jul 16.
PubMed 39014905
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sample Size Determination in Heterogeneous Populations for Multivariate Time-to-event Data
- ClinicalTrials.gov ID
- NCT03964402
- Acronym / sponsor ID
- IB2018-SAMPLE-SIZE-SURVIVAL
- Conditions
- Clinical Trials
- Keywords
- sample size, survival, randomized clinical trials, statistical test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most of randomized clinical trials (RCT) using time-to-event criteria as the primary endpoint are designed, powered and analyzed based on an hypothetical hazard ratio (HR) corresponding to the targeted effect size between experimental and control arms. Usually, one assumes that populations are homogeneous within each treatment arm, that is, within each arm, (i) the baseline risk is identical for all patients, and (ii) the treatment effect is identical for all patients. This assumption however may not hold in all circumstances. This project aims at providing a statistical method for the estimation of sample size in RCT, in the presence of heterogenous populations, such as assuming populations with distinct underlying baseline risks or assuming different treatment effects.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical trial | – | –Corresponds to a comparative clinical trial for which our new statistical methods will be applied to estimate sample size |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any comparative clinical trial for which modern statistical methods are required to estimate sample size, in particular, it can be clinical trials : * with heterogeneous populations, * with recurrent event data, * involving a biomarker-Strategy Designs With Multiple Treatments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 2 years
time from randomization to death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Background: PubMed 34242412Dinart D, Bellera C, Rondeau V. Sample size estimation for cancer randomized trials in the presence of heterogeneous populations. Biometrics. 2022 Dec;78(4):1662-1673. doi: 10.1111/biom.13527. Epub 2021 Sep 3.
- Background: PubMed 38334044Dinart D, Bellera C, Rondeau V. Sample size estimation for recurrent event data using multifrailty and multilevel survival models. J Biopharm Stat. 2025 Mar;35(2):241-256. doi: 10.1080/10543406.2024.2310306. Epub 2024 Feb 9.
- Background: PubMed 39014905Dinart D, Rondeau V, Bellera C. Sample Size Estimation Using a Partially Clustered Frailty Model for Biomarker-Strategy Designs With Multiple Treatments. Pharm Stat. 2024 Nov-Dec;23(6):1084-1094. doi: 10.1002/pst.2407. Epub 2024 Jul 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carine Bellera, PhD principal investigator
Institut Bergonié
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Trials, run by Institut Bergonié at 1 site in France.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03964402, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.